Scott Usa, Inc.
⚠️ Moderate Risk
FEI: 3023101 • Ketchum, ID • UNITED STATES
FEI Number
3023101
Location
Ketchum, ID
Country
UNITED STATESAddress
101 Lewis Street, , Ketchum, ID, United States
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/29/2014 | 86HOYSHIELD, EYE, OPHTHALMIC (INCLUDING SUNLAMP PROTECTIVE EYEWEAR AND POST-MYDRIATIC EYEWEAR) | 341REGISTERED | New England District Office (NWE-DO) |
| 10/29/2014 | 86HOYSHIELD, EYE, OPHTHALMIC (INCLUDING SUNLAMP PROTECTIVE EYEWEAR AND POST-MYDRIATIC EYEWEAR) | 341REGISTERED | New England District Office (NWE-DO) |
| 10/29/2014 | 86HOYSHIELD, EYE, OPHTHALMIC (INCLUDING SUNLAMP PROTECTIVE EYEWEAR AND POST-MYDRIATIC EYEWEAR) | 341REGISTERED | New England District Office (NWE-DO) |
| 10/29/2014 | 86HOYSHIELD, EYE, OPHTHALMIC (INCLUDING SUNLAMP PROTECTIVE EYEWEAR AND POST-MYDRIATIC EYEWEAR) | 341REGISTERED | New England District Office (NWE-DO) |
| 10/29/2014 | 86HOYSHIELD, EYE, OPHTHALMIC (INCLUDING SUNLAMP PROTECTIVE EYEWEAR AND POST-MYDRIATIC EYEWEAR) | 341REGISTERED | New England District Office (NWE-DO) |
Frequently Asked Questions
What is Scott Usa, Inc.'s FDA import refusal history?
Scott Usa, Inc. (FEI: 3023101) has 5 FDA import refusal record(s) in our database, spanning from 10/29/2014 to 10/29/2014.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Scott Usa, Inc.'s FEI number is 3023101.
What types of violations has Scott Usa, Inc. received?
Scott Usa, Inc. has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Scott Usa, Inc. come from?
All FDA import refusal data for Scott Usa, Inc. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.